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CTRI Number  CTRI/2024/06/069195 [Registered on: 19/06/2024] Trial Registered Prospectively
Last Modified On: 28/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Study of management in adult patients having obstruction in their main windpipe 
Scientific Title of Study   Prospective Observational Study Of Perioperative Airway Management In Adult Patients With Central Airway Obstruction  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Madhavi Shetmahajan 
Designation  Professor 
Affiliation  Tata memorial Centre, Mumbai 
Address  Dept of Anaesthesiology, Critical Care and Pain, tata Memorial hospital, parel, mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9819372075  
Fax    
Email  mshetmahajan@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Madhavi Shetmahajan 
Designation  Professor 
Affiliation  Tata memorial Centre, Mumbai 
Address  Dept of Anaesthesiology, Critical Care and Pain, tata Memorial hospital, parel, mumbai


MAHARASHTRA
400012
India 
Phone  9819372075  
Fax    
Email  mshetmahajan@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  J Ashwin priyadarshan 
Designation  Junior Registrar II 
Affiliation  Tata Memorial Centre, Mumbai 
Address  Dept of Anaesthesiology, Critical Care and Pain, tata Memorial hospital, parel, mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  8456063581  
Fax    
Email  aswinpriyadarshan@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Centre, E borges marg, parel, mumbai 400012 india 
 
Primary Sponsor  
Name  Tata memorial Centre Mumbai 
Address  Tata memorial centre, E borges rd, Parel, Mumbai , India 400012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Madhavi Shetmahajan  Tata memorial Hospital  Operation theatre complex, anaesthesia department, E Borges Marg, Parel, mumbai 400012 India
Mumbai
MAHARASHTRA 
9819372075

mshetmahajan@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Centre Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  All adult patients with central airway obstruction undergoing anaesthesia in emergency and elective setting 
 
ExclusionCriteria 
Details  Paediatric patients
Supraglottic obstruction and obstruction distal to mainstem bronchi
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Preference of different types of airway management plan based on site and degree of obstruction  After intubation or alternative airway control intraoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
2. Success rate of primary plan (plan A) of airway management.
3. Complications during airway management.
4. Number of cases with uncontrolled desaturation to less than 90 percent during airway management.
 
Intraoperatively, postoperative day 1, at discharge from hospital 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   27/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Airway obstruction is a potentially life threatening condition with a wide variety of aetiologies that can lead to a number of complications ranging from respiratory failure, arrhythmias, cardiac arrest and even death.

In general, airway obstruction is broadly classified into upper airway obstruction which refers to the obstruction of air flow in the portion of the airway that extends from the nose till the trachea and therefore includes the nasopharynx and larynx. Central airway obstruction which refers to the obstruction of airflow in the trachea and mainstem bronchi. Lower airway obstruction refers to the obstruction distal to the mainstem bronchi.

Causes of central airway obstruction are typically classified as malignant or nonmalignant or in accordance to the location ie intraluminal or extraluminal or according to the nature of the obstruction ie dynamic (eg;tracheobronchomalacia) or fixed.

Management of central airway obstruction is complex and challenging. Management is usually individualised rather than protocolised. There are no clear guidelines regarding anaesthesia techniques for airway management. General anaesthesia with inhalational or intravenous techniques, with or without muscle relaxants or awake techniques for airway control may be used based on the type and degree of airway obstruction, experience of the anaesthesiologist and availability of equipment.                                                                                                                                                                               

This prospective observational study is aimed at understanding the airway management practices and outcomes in patients with central airway obstruction undergoing anaesthesia in our institute. 


The main objectives of the study is to

1)Assessment of the location, extent and nature of the obstruction based on radioimaging/fibreoptic nasoendoscopy, PFT and other modalities.

2)Assessment of the airway equipment used to secure the airway based on the location, extent, nature of the obstruction and other patient factors.

3)Assessment of the factors considered while planning the airway strategy (eg;awake or under GA).

4)Assess the impact of the proposed airway management in patient outcome. 

The total study duration is 2 years.The total sample size is 200 patients.

All adult  patients in Tata Memorial Hospital,Parel with central airway obstruction undergoing anaesthesia in emergency and elective setting will be included in the study after taking an written informed consent.

Data will be collected in the Case Record Form. Details regarding patient characteristics, surgical procedure and anaesthesia details will be collected prospectively from the patients’ electronic and physical records. Details regarding airway management plan and its success, failure and complications will be captured. 

Demographic data will be summarized with descriptive statistics. Continuous data will be represented as mean (Standard deviation), or Median (IQR) and categorical data will be reported in counts (percentage) respectively. The Shapiro-Wilk’s test will be used to check normality of each variable. Categorical data will be compared using chi square test such like Pearson’s chi square test and fisher’s exact test. Comparison of continuous data will be done by using t test or Mann Whitney U test.

 
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